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Completed

NCT Number: NCT05033041

Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide

Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently recommends metoclopramide administration prior to cesarean deliveries.

We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.

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Key information

Conditions

Pregnancy Aspiration Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Memorial Hospital and Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy (ASA Physical Status 2)
  • Age >18 years old
  • Non-obese (BMI <40 kg/m2)
  • Age >18 years
  • Term (>37 week)
  • Non-laboring parturient
  • Single gestation
  • Scheduled for a cesarean delivery and NPO

Exclusion criteria

  • Systemic disease such as diabetes mellitus (type 1 or 2)
  • Multiple gestation
  • Abnormality of upper GI tract
  • History of GI tract related surgical procedures
  • Use of gastric motility medications
  • Active labor
  • Renal impairment (creatinine >2)
  • Non-English speaking
  • Cognitively impaired
  • History of QT prolongation
  • Use of general anesthesia

Treatment and study plan

Study drug metoclopramide

Drug

Intravenous administration of 10 mg metoclopramide

Study drug placebo administration

Drug

Intravenous administration of placebo (sterile normal saline)

Primary outcomes

  1. Change in Gastric Volume (mL)

    Time frame: 30 minutes after administration of study drug

    Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6*(RLD CSA (cm2)-1.28 * age)) and the Roukhomovsky method (volume=(0.18*RLD CSA (mm2))+(0.11*SUP CSA (mm2)-62.4) methods.

Secondary outcomes

  1. Subject Report of Nausea During Cesarean Section

    Time frame: 24 hours

    Subject reported intraoperative nausea during the cesarean delivery

  2. Adverse Events

    Time frame: 72 hours

    Number of reported adverse events experienced for each group.

  3. Intraoperative Nausea Occurrences

    Time frame: 24 hours

    Number of nausea occurrences during cesarean section procedure

  4. Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes

    Time frame: 24 hours

    Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant.

  5. Subject Experienced Vomiting During Cesarean Section

    Time frame: 24 Hours

    Subject experienced vomiting episode during the cesarean delivery procedure.

  6. Number of Intraoperative Vomiting Occurrences

    Time frame: 24 Hours

    Number of intraoperative vomiting occurrences during the cesarean section.

  7. Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.

    Time frame: 24 Hours

    The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during.

  8. Antiemetic Prophylaxis

    Time frame: 24 Hours

    Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section.

  9. PACU Antiemetic Treatment (n)

    Time frame: 24 hours

    Number of participants who required antiemetic medications in the post anesthesia care unit

  10. Nausea After PACU Discharge

    Time frame: 72 hours

    Number of participants who experienced nausea after being discharged from the post anesthesia care unit

  11. Elapsed Time From Study Drug to Second Ultrasound

    Time frame: 24 hours

    Total elapsed time in minutes after study drug administered to second gastric ultrasound.

  12. Second Ultrasound Cross Sectional Area (cm^2)

    Time frame: 24 hours

    The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered

  13. Post Treatment Estimated Volume (mL) Second Ultrasound

    Time frame: 24 hours

    Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration

  14. Second Ultrasound Volume >1.5 * Weight (kg)

    Time frame: 24 hours

    Number of subjects experiencing a volume greater than than 1.5 times weight in kilograms after the second gastric ultrasound 30 minutes after study medication administration.

Other outcomes

  1. First Ultrasound Stomach Cross-sectional Area (cm2)

    Time frame: After consent obtained

    The first ultrasound of the stomach cross-sectional area in centimeters squared.

  2. First Ultrasound Volume Greater Than 1.5 * Weight (kg)

    Time frame: After consent obtained

    The first ultrasound calculated volume greater than 1.5 times weight in kilograms.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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